A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

Inclusion Criteria:

• A male or female participant ≥50 YOA at the time of the first study interventionadministration.

• Female participants of non-childbearing potential may be enrolled in the study.

• Female participants of childbearing potential may be enrolled in the study, if theparticipant:

• has practiced adequate contraception from 1 month prior to study interventionadministration.

• has a negative pregnancy test on the day of and prior to study interventionadministration.

• has agreed to continue effective contraception until the end of the study.

• Participants who, in the opinion of the investigator, can and will comply with therequirements of the protocol. Written or witnessed informed consent obtained fromthe participant prior to any study specific procedure being performed.

• Participants living in the general community or in an assisted-living facility thatprovides minimal assistance, such that the participant is primarily responsible forself-care and activities of daily living.

• Participants who are medically stable in the opinion of the investigator at the timeof first study intervention administration. Participants with chronic stable medicalconditions with or without specific treatment, such as diabetes mellitus,hypertension, or cardiac disease, are allowed to participate in this study ifconsidered by the investigator as medically stable.

Exclusion Criteria:

• Pregnant or lactating female.

• Female planning to become pregnant or planning to discontinue contraceptiveprecautions.

• Any confirmed or suspected autoimmune disorders, immunosuppressive orimmunodeficient condition resulting from disease or immunosuppressive/cytotoxictherapy, based on medical history and physical examination.

• History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study interventions, in particular any history of severe allergicreaction to any vaccine component.

• History of Guillain-Barré syndrome.

• Any history of dementia or any medical condition that moderately or severely impairscognition.

• Recurrent or uncontrolled neurological disorders or seizures. Participants withmedically controlled chronic neurological diseases can be enrolled in the study asper investigator assessment, provided that their condition will allow them to complywith the requirements of the protocol.

• Significant underlying illness that in the opinion of the investigator would beexpected to prevent completion of the study.

• Any medical condition that in the judgment of the investigator would makeintramuscular injection unsafe.

• Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode ofherpes zoster.

• History of previous vaccination with any licensed or investigational recombinantadjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start orplanned receipt through study participation.

• History of previous vaccination with any licensed or investigational live herpeszoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receiptthrough study participation.

• Previous vaccination with licensed or investigational RSV vaccine.

• Use of any investigational or non-registered product (drug, vaccine or medicaldevice) other than the study interventions during the period beginning 30 daysbefore the first dose of study interventions, or their planned use during the studyperiod.

• Planned or actual administration of a vaccine not foreseen by the study protocol inthe period starting 30 days before the first study intervention administration andending 30 days after the last study intervention administration. o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, thistime window can be decreased to 14 days before and after each study interventionadministration provided COVID-19 vaccine use is in line with local governmentalrecommendations.

• Planned or actual administration of adjuvanted quadrivalent influenza vaccineinfluenza vaccine not foreseen by the study protocol in the period starting 30 daysbefore the first study intervention administration and ending 30 days after the laststudy intervention administration.

• Administration of long-acting immune-modifying drugs during the period starting 180days before the administration of first dose of study interventions or plannedadministration at any time during the study period (e.g., infliximab).

• Administration of immunoglobulins and/or any blood products or plasma derivativesduring the period starting 90 days before the administration of first dose of studyinterventions or planned administration during the study period.

• Chronic administration (defined as more than 14 consecutive days in total) ofimmunosuppressants or other immune modifying drugs during the period starting 90days prior to the first study intervention dose or planned administration during thestudy period. For corticosteroids, this will mean prednisone ≥20 mg/day, orequivalent. Inhaled, topical or intra-articular steroids are allowed.

• Concurrently participating in another clinical study, at any time during the studyperiod, in which the participant has been or will be exposed to an investigationalor a non investigational vaccine/product (IMP) (drug or invasive medical device).

• History of chronic alcohol consumption and/or drug abuse as deemed by theinvestigator to render the potential participant unable/unlikely to provide accuratesafety reports or comply with study procedures.Bedridden participants.

• Planned move during the study conduct that prohibits participation until study end.

• Participation of any study personnel or their immediate dependents, family, orhousehold members.